BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1842238 · Received September 23, 2010

    Report

    Report Number
    1823260-2010-05641
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 266 MG/DL (B)(4) AND 94 MG/DL (B)(4). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, STRIPS HAVE BEEN USED AND ARE NO LONGER AVAILABLE. REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551299

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR SULAR 1X DAILY| METFORMIN 2X DAILY| DYAZIDE 1X DAILY| MULTIVITAMIN 1X DAILY| LISINOPRIL 1X DAILY| NOVOLIN 70/30 2X DAILY| CELEXA 1X DAILY| ASPIRIN 1X DAILY